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目的:建立高效液相色谱法测定1,25-二羟基维生素D_2纳米乳注射液含量。方法:采用C18-STⅡ色谱柱(4.6×250 mm,5μm);流动相为乙腈-水=85:15(V/V);流速:1.5 m L/min;检测波长:274 nm;温度:室温;进样量:200μL。结果:该方法专属性好,平均回收率99.96%(RSD为0.63%,n=9);溶液在冷藏(2~6℃)保存24 h稳定(RSD=0.98%,n=7);在0.06μg/m L~4.0μg/m L范围内线性关系良好,其回归方程为:Y=201098 X-8412.5(R2=0.9998,n=9)。结论:该方法简便、快捷、灵敏度高、专属性强,可用于该注射液的含量测定。
Objective: To establish a HPLC method for the determination of 1,25-dihydroxyvitamin D_2 nanoemulsion injection. Method: C18-STⅡ column (4.6 × 250 mm, 5μm) was used. The mobile phase consisted of acetonitrile-water = 85:15 (V / V), flow rate was 1.5 m L / min, detection wavelength was 274 nm, ; Injection volume: 200μL. The results showed that the method was of good specificity and the average recovery was 99.96% (RSD = 0.63%, n = 9). The solution was stable for 24 h after storage at 2-6 ℃ (RSD = 0.98%, n = 7) The regression equation was Y = 201098 X-8412.5 (R2 = 0.9998, n = 9) with good linearity in the range of μg / m L to 4.0 μg / m L. Conclusion: The method is simple, rapid, sensitive, specific and can be used for the determination of the content of the injection.